Patient interface and aspects thereof

ABSTRACT

A ballooning patient interface has a frame that supports a sealing member. The frame and/or the sealing member is secured to the head of a user with headgear, such as a strap. Various features of the sealing member improve comfort for the user in the nares of the users as well as on facial surfaces in contact with the sealing member.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference herein in theirentireties and made a part of the present disclosure.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to interfaces for providing asupply of pressurised gas to a recipient.

2. Description of the Related Art

Breathing gases can be delivered to users with a variety of differentmask styles and can be delivered for a variety of different purposes.For example, users can be ventilated using non-invasive ventilation(NIV). In addition, continuous positive airway pressure (CPAP) orvariable airway pressure can be delivered using masks to treat a medicaldisorder, such as obstructive sleep apnea (OSA), chronic obstructivepulmonary disease (COPD), or congestive heart failure (CHF).

These non-invasive ventilation and pressure support therapies generallyinvolve the placement of a user interface device, which is typically anasal or nasal/oral mask, on the face of a user. The flow of breathinggas can be delivered from the pressure/flow generating device to theairway of the user through the mask.

Typically, patient interface devices include a mask frame that supportsa sealing member. The sealing member contacts the facial surfaces of theuser, including regions surrounding the nose, including the nose and thenares. Because such masks are typically worn for an extended period oftime, a variety of concerns must be taken into consideration. Forexample, in providing CPAP to treat OSA, the user normally wears themask all night long while he or she sleeps. One concern in such asituation is that the mask should be as comfortable as possible. It isalso important that the mask provide a sufficient seal against a user'sface without significant discomfort.

SUMMARY OF THE INVENTION

Accordingly, it is an object of certain embodiments of the presentinvention to provide an improved sealing member for use in a maskassembly that overcomes the shortcomings of conventional sealingmembers.

In some configurations, a nasal seal configured to be removably coupledto a frame of a patient interface or a patient interface incorporating aseal includes a seal body formed of a soft flexible material anddefining an inner cavity and one or more delivery openings for supply ofbreathing gases from the inner cavity to the patient. The seal bodycomprises a central portion and a side portion extending from each endof the central portion. The seal body further comprises an interior sideand an exterior side, wherein the interior side of the central portionis configured to extend across a base of a user's nose and the interiorside of each of the side portions is configured to extend across a sideof the nose. The interior side of the seal is supple and configured toconform under internal pressure to surfaces of the user's nose,including, at the side portions of the seal, to outside surfaces of theside of the nose. Each of the side portions defines a transition portionbetween the exterior side and the interior side, wherein the exteriorside of each of the side portions comprises stiffened regions that arestiffer or much stiffer than the supple interior side, the stiffenedregions extending to or substantially to the transition portions.

In some such configurations, the stiffened regions are formed byrelatively thickened portions of the seal body. The thickened portionscan taper in thickness before the transition portions. The transitionportions can include a portion that is thicker than the supple interiorside.

In some such configurations, the stiffened regions extend substantiallyalong an entire length of the exterior side of the seal body.

In some such configurations, the transition portions comprise roundedwall sections.

In some such configurations, a support is formed of a relatively rigidmaterial and supports a portion of the seal body. The support can defineat least one grip surface portion extending along the exterior side ofthe seal body. The at least one grip surface portion can comprise atleast one pair of grip surface portions substantially opposite oneanother.

In some such configurations, the support defines a mount for mountingthe nasal seal to the frame. The mount can comprise a first member thatis connectable to a second member, wherein the first member and thesecond member capture a portion of the seal body between them. The firstmember can be positioned within a cavity of the seal body and cancomprise a sleeve portion that extends outwardly from the cavity. Thesecond member can surround the sleeve portion of the first member.

In some such configurations, the stiffened regions are disposed inrearmost and lowermost sections of the side portions. The rearmost andlowermost sections of the side portions can flare outwardly relative toadjacent portions of the seal body.

In some such configurations, the one or more delivery openings comprisea first delivery opening and a second delivery opening. The nasal sealcan further comprise a nostril locator associated with and forming aportion of each delivery opening, wherein a deflection region is definedwithin an annular transition portion between each of the nostrillocators and a surrounding portion of the interior side. The deflectionregion has a lower stiffness relative to another region of the annulartransition portion not within the deflection region.

In some such configurations, the lower stiffness is achieved by thedeflection regions having a smaller thickness than the other regions ofthe annular transition portion. The deflection regions can be located onthe outer sides of the nostril locators. The deflection regions can belimited to less than or equal to one-half of the annular transitionportion.

In some such configurations, the central portion of the seal bodydefines a thinned region that permits forward movement of an upperportion of the interior side of the central portion as a result ofrolling movement of the seal body.

In some configurations, a nasal seal configured to be removably coupledto a frame of a patient interface or a patient interface incorporating aseal includes a seal body formed of a soft flexible material anddefining an inner cavity and one or more delivery openings for supply ofbreathing gases from the inner cavity to the patient. The seal bodycomprises a central portion and a side portion extending from each endof the central portion. The seal body further comprises an interior sideand an exterior side, wherein the interior side of the central portionis configured to extend across a base of a user's nose and the interiorside of each of the side portions is configured to extend across a sideof the nose. The interior side of the seal is supple and configured toconform under internal pressure to surfaces of the user's nose,including, at the side portions of the seal, to outside surfaces of theside of the nose. The exterior side of each of the side portionscomprises stiffened regions that are stiffer or much stiffer than thesupple interior side, the stiffened regions being disposed in a rearmostand lowermost sections of the side portions.

In some such configurations, the rearmost and lowermost sections of theside portions flare outwardly relative to adjacent portions of the sealbody.

In some such configurations, the flared side portions are generallyaligned with surfaces of the user's cheek or upper lip laterally outwardof the nose.

In some such configurations, the stiffened regions are formed byrelatively thickened portions of the seal body.

In some such configurations, the thickened portions taper in thicknessbefore transition portions between the interior side and the exteriorside.

In some such configurations, the transition portions include a portionthat is thicker than the supple interior side.

In some configurations, a nasal seal configured to be removably coupledto a frame of a patient interface or a patient interface incorporating aseal includes a seal body formed of a soft flexible material anddefining an inner cavity and one or more delivery openings for supply ofbreathing gases from the inner cavity to the patient. The seal bodycomprises a central portion and a side portion extending from each endof the central portion. The seal body further comprises an interior sideand an exterior side. The interior side of the central portion isconfigured to extend across a base of a user's nose and the interiorside of each of the side portions is configured to extend across a sideof the nose. The interior side of the seal is supple and configured toconform under internal pressure to surfaces of the user's nose,including, at the side portions of the seal, to outside surfaces of theside of the nose. The exterior side of each of the side portionscomprises stiffened regions that are stiffer or much stiffer than thesupple interior side. The exterior side of the seal body further definesa grip surface on each of the side portions, the grip surfaces locatedon the stiffened regions.

In some such configurations, the grip surface is formed by a protrusion.

In some such configurations, the protrusion is generallycrescent-shaped, thereby defining a generally scallop-shaped gripsurface.

In some such configurations, the ends of the protrusion are positionedrearward of the center, curved portion of the protrusion.

In some configurations, a nasal seal configured to be removably coupledto a frame of a patient interface or a patient interface incorporating aseal includes a seal body formed of a soft flexible material anddefining an inner cavity and one or more delivery openings for supply ofbreathing gases from the inner cavity to the patient. The seal bodycomprises a central portion and a side portion extending from each endof the central portion. The seal body further comprises an interior sideand an exterior side. The interior side of the central portion isconfigured to extend across a base of a user's nose and the interiorside of each of the side portions is configured to extend across a sideof the nose. The interior side of the seal is supple and configured toconform under internal pressure to surfaces of the user's nose,including, at the side portions of the seal, to outside surfaces of theside of the nose. The nasal seal further comprises a support formed of arelatively rigid material and supporting a portion of the seal body. Thesupport defines at least one grip surface portion extending along theexterior side of the seal body.

In some such configurations, the support defines at least one gripsurface portion extending along the exterior side of the seal body.

In some such configurations, the at least one grip surface portioncomprises at least one pair of grip surface portions substantiallyopposite one another.

In some such configurations, the support defines a mount for mountingthe nasal seal to the frame.

In some such configurations, the mount comprises a first member that isconnectable to a second member, wherein the first member and the secondmember capture a portion of the seal body between them.

In some such configurations, the first member is positioned within acavity of the seal body and comprises a sleeve portion that extendsoutwardly from the cavity.

In some such configurations, the second member surrounds the sleeveportion of the first member.

In some configurations, a nasal seal configured to be removably coupledto a frame of a patient interface or a patient interface incorporating aseal includes a seal body formed of a soft flexible material anddefining an inner cavity. The seal body comprises a central portion anda side portion extending from each end of the central portion. The sealbody further comprises an interior side and an exterior side. Theinterior side of the central portion is configured to extend across abase of a user's nose and the interior side of each of the side portionsis configured to extend across a side of the nose. The interior side ofthe seal is supple and configured to conform under internal pressure tosurfaces of the user's nose, including, at the side portions of theseal, to outside surfaces of the side of the nose. The seal bodycomprises a first delivery opening and a second delivery opening forsupply of breathing gases from the inner cavity to the nostrils of theuser. A nostril locator is associated with and forms a portion of eachdelivery opening. A deflection region is defined within a transitionportion between each of the nostril locators and a surrounding portionof the interior side. The deflection region has a lower stiffnessrelative to another region of the transition portion not within thedeflection region.

In some configurations, the deflection regions have a lower thicknessthan the other region of the transition portion.

In some configurations, the deflection regions are located on an outerside of the nostril locators to facilitate movement of the nostrillocators outwardly away from one another.

In some configurations, the deflection regions are limited to less thanor equal to one-half of the transition portion, which can be generallyannular in shape.

In some configurations, a patient interface or a seal arrangement for apatient interface comprises a first delivery opening and a seconddelivery opening for supply of breathing gases from the inner cavity tothe nostrils of the user. A nostril locator or seal member (e.g., nasalpillow) is associated with and forms a portion of each delivery opening.A deflection region is defined within an annular transition portionbetween each of the nostril locators or seal members and a surroundingportion of the seal arrangement. The deflection region has a lowerstiffness relative to another region of the transition portion notwithin the deflection region. The lower stiffness may be accomplished bya lower wall thickness within the deflection region compared to theother region. The deflection region may be located on the outsides ofthe nostril locators or seal members to facilitate outward tilting. Thedeflection region may be limited to less than or equal to about one-halfof the annular transition portion, which can be generally annular inshape.

In some configurations, a sealing member is provided for a mask with thesealing member having any set or subset of features or any combinationof sets or subsets of features described herein. In some suchconfigurations, a mask can have such a sealing member.

In some configurations, a seal member comprises a proximal surface and adistal surface. The proximal surface has one or more delivery openingsfor supply of breathing gases to the patient. The proximal surface andthe distal surface define an inner cavity within the seal member. Atleast one integrated support structure underlies at least a portion ofthe inner cavity.

In some such configurations, the at least one integrated supportstructure comprises a crescent shaped member that is structurallyintegrated into the seal member.

In some such configurations, the at least one integrated supportstructure extends at least partially upward along at least a portion ofthe distal surface. In some such configurations, the at least oneintegrated support structure extends upwardly along the distal surface.In some such configurations, a portion of the at least one integratedsupport structure that extends upwardly along the distal surface extendsproximally and is configured to provide support relative to a region ofa user along a cheek region.

In some such configurations, the portion of the integrated supportstructure that underlies the inner cavity extends proximally and isconfigured to provide support relative to a region of a user just abovea lip.

In some such configurations, the integrated support structure comprisesone or more thickened regions of the seal member. In some suchconfigurations, the thickened regions incorporate a hollow region havinganother material positioned within hollow region of the integratedsupport structure.

In some such configurations, the at least one integrated supportstructure is positioned in a marginal surface that connects the proximalsurface to the distal surface. In some such configurations, the marginalsurface is wider at a bottom portion than at a top portion. In some suchconfigurations, the seal member has a thicker wall in a region thatincludes the bottom portion of the marginal surface relative to a regiongenerally surrounding the one or more delivery openings. In some suchconfigurations, the region with the thicker wall extends upwardly fromthe bottom portion of the marginal surface.

In some such configurations, the at least one integrated supportstructure is positioned to be in a widest lateral region of the sealmember.

In some such configurations, the at least one integrated supportstructure extends most proximally of any other portion of the sealmember.

In some such configurations, the at least one integrated supportstructure is positioned to be in a widest lateral region of the sealmember and extends most proximally of any other portion of the sealmember.

Various features, aspects and advantages of the present invention can beimplemented in any of a variety of manners. For example, while severalembodiments will be described herein, sets or subsets of features fromany of the embodiments can be used with sets or subsets of features fromany of the other embodiments.

The term “comprising” is used in the specification and claims, means“consisting at least in part of”. When interpreting a statement in thisspecification and claims that includes “comprising”, features other thanthat or those prefaced by the term may also be present. Related termssuch as “comprise” and “comprises” are to be interpreted in the samemanner.

In this specification where reference has been made to patentspecifications, other external documents, or other sources ofinformation, this is generally for the purpose of providing a contextfor discussing the features of the invention. Unless specifically statedotherwise, reference to such external documents is not to be construedas an admission that such documents, or such sources of information, inany jurisdiction, are prior art, or form part of the common generalknowledge in the art.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the presentinvention will be described with reference to the following drawings.

FIG. 1 is a front view of an interface assembly that is arranged andconfigured in accordance with certain features, aspects and advantagesof the present invention.

FIG. 2 is a side view of the interface assembly of FIG. 1.

FIG. 3 is a rear view of the interface assembly of FIG. 1.

FIG. 4 is an illustration of a user donning an interface assembly havingcertain characteristics in common with the interface assembly of FIG. 1.

FIG. 5 is a partially exploded view of a portion of an interfaceassembly that is arranged and configured in accordance with certainfeatures, aspects and advantages of the present invention.

FIG. 6 is a view of a portion of an interface assembly that is arrangedand configured in accordance with certain features, aspects andadvantages of the present invention.

FIG. 7 is a view of a portion of an interface assembly that is arrangedand configured in accordance with certain features, aspects andadvantages of the present invention.

FIG. 8 is a view of a portion of an interface assembly that is arrangedand configured in accordance with certain features, aspects andadvantages of the present invention.

FIGS. 9A-9F are views of portions of an interface assembly that arearranged and configured in accordance with certain features, aspects andadvantages of the present invention.

FIG. 10 is a view of a portion of an interface assembly that is arrangedand configured in accordance with certain features, aspects andadvantages of the present invention.

FIG. 11 is a view of a portion of an interface assembly that is arrangedand configured in accordance with certain features, aspects andadvantages of the present invention.

FIG. 12 is a view of a portion of an interface assembly that is arrangedand configured in accordance with certain features, aspects andadvantages of the present invention.

FIG. 13 is a view of a portion of an interface assembly that is arrangedand configured in accordance with certain features, aspects andadvantages of the present invention.

FIG. 14A-14D are views of portions of interface assemblies that arearranged and configured in accordance with certain features, aspects andadvantages of the present invention.

FIGS. 15A-15D are views of a portion of an interface assembly that isarranged and configured in accordance with certain features, aspects andadvantages of the present invention.

FIG. 16 is a rear view of a portion of an interface assembly that isarranged and configured in accordance with certain features, aspects andadvantages of the present invention.

FIG. 17 is a bottom view of the portion of the interface assembly ofFIG. 16.

FIG. 18 is a perspective view of the portion of the interface assemblyof FIG. 16.

FIG. 19 is a view of a portion of an interface assembly that is arrangedand configured in accordance with certain features, aspects andadvantages of the present invention.

FIGS. 20A-20E are views of portions of interface assemblies that arearranged and configured in accordance with certain features, aspects andadvantages of the present invention.

FIG. 21 is a view of a portion of an interface assembly that is arrangedand configured in accordance with certain features, aspects andadvantages of the present invention.

FIG. 22 is a view of a portion of a nasal cavity and a portion of aninterface assembly that is arranged and configured in accordance withcertain features, aspects and advantages of the present invention.

FIGS. 23A-23C are views of portions of interface assemblies that arearranged and configured in accordance with certain features, aspects andadvantages of the present invention.

FIG. 24 is a view of a portion of an interface assembly that is arrangedand configured in accordance with certain features, aspects andadvantages of the present invention.

FIGS. 25A and 25B are views of a prior interface assembly and aninterface assembly arranged and configured in accordance with certainfeatures, aspects and advantages of the present invention.

FIG. 26 is a view of an interface assembly that is arranged andconfigured in accordance with certain features, aspects and advantagesof the present invention.

FIG. 27 is a view of another interface assembly that is arranged andconfigured in accordance with certain features, aspects and advantagesof the present invention.

FIG. 28 is a view of another interface assembly that is arranged andconfigured in accordance with certain features, aspects and advantagesof the present invention.

FIG. 29 is a partially exploded perspective view of an interfaceassembly that is arranged and configured in accordance with certainfeatures, aspects and advantages of the present invention.

FIG. 30 is a more fully exploded perspective view of the interfaceassembly of FIG. 29.

FIG. 31 is a perspective view of the interface assembly of FIG. 29.

FIG. 32 is a sectioned view taken along the line 32-32 in FIG. 31.

FIG. 33 is a sectioned view taken along the line 33-33 in FIG. 32.

FIG. 34 is an enlarged view of a portion of FIG. 33.

FIGS. 35-37 are views of a seal member of the interface assembly of FIG.29 illustrating material thicknesses of the proximal wall.

FIGS. 38-40 are views of the seal member illustrating materialthicknesses of the distal wall.

FIG. 41 is an enlarged view of a portion of the section of the sealmember shown in FIG. 33.

FIG. 42 is a rear view of the seal member of the interface assembly ofFIG. 29.

FIG. 43 is a sectioned view of another interface assembly that isarranged and configured in accordance with certain features, aspects andadvantages of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates a patient interface 100 that is arranged andconfigured in accordance with certain features, aspects and advantagesof the present invention. The interface 100 can be used to supplypressurized breathing gases to a recipient. The interface 100 is wellsuited for providing breathing gases to the recipient in situationswhere significant pressure changes are likely to be encountered. Forexample but without limitation, the interface 100 can be used fordelivering continuous positive airway pressure (CPAP).

With continued reference to FIG. 1, the interface 100 is shown separatefrom a patient who would wear the interface 100. Some aspects of thepatient interface 100, and variations on each aspect, have beendescribed in U.S. patent application Ser. No. 12/945,141, filed Nov. 12,2010, which is hereby incorporated by reference in its entirety. Theinterface 100 broadly comprises a mask 102. In some configurations, astrap 104 can attach to the mask 102 and can be used to secure the mask102 to the patient. In some configurations, the interface 100 alsocomprises a flexible supply conduit 106 that can connect to the mask102.

With continued reference to FIG. 1 and with additional reference to FIG.2, the mask 102 is configured to fit over or overlie both nostrils ofthe patient. In some configurations, the mask 102 can include lateralportions 110 (see FIG. 2) that are configured to curve around towardeach lateral side of a nose of the patient. These lateral portions 110can form a perimeter seal on outwardly facing surfaces of flanks of thenose. The strap 104 can pass around the user's head in a simple loopabove the user's ears.

The flexible conduit 106 can depend from a central connection 112. Insome configurations, the central connection 112 can be positioned at afrontal portion of the mask 102. The central connection 112 preferablycomprises a swiveling elbow. The elbow can enable the flexible conduit106 to pivot relative to the mask 102. By enabling pivoting, the elbowcan help the interface 100 to better adapt to the sleeping position ofthe patient. In some configurations, the central connection 112 maycomprise a ball joint so that the elbow can pivot about axes parallel toand perpendicular to its connection with the mask 102.

The illustrated mask 102 generally comprises a seal 114 and a body orframe 116. The seal 114 and the frame 116 can be connected in anysuitable manner.

The seal 114 preferably defines a supple pocket or envelope that cancontain a recess region. In some configurations, the seal 114 cancomprise a low wall thickness and can be formed of any suitablematerial. For example but without limitation, the seal 114 can be formedof latex, vinyl, silicone or polyurethane. In some configurations, thewall thickness can be below about 0.5 mm and could be lower than about0.2 mm in some regions and in some configurations. In someconfigurations, the seal 114 can be formed of a material havingsufficient elasticity and yield strength so that the combination rendersthe seal 114 supple. The seal 114 preferably is capable of withstandingrepeated drastic deformations without failure.

With reference to FIG. 3, the seal 114 preferably comprises one or twonostril locators 120. The nostril locators 120 can protrude from theseal 114. In some configurations, the nostril locators extend generallyupwardly and rearwardly from a proximal wall 124 of the seal 114. Insome configurations, the nostril locators 120 extend generallyrearwardly from the proximal wall 124 of the seal 114.

In the configuration illustrated in FIGS. 1-3, the nostril locators 120are formed integrally (i.e., in one monolithic piece) with the seal 114.Each nostril locator 120 can comprise an outlet aperture 118 throughwhich gas can be supplied from the flexible conduit 106. In someconfigurations, the gas can be supplied from within the pocket orenvelope defined by the seal 114. In other configurations, the gas thatis supplied can be separate from the gas supplied to the pocket orenvelope defined by the seal 114.

The seal 114 generally comprises a distal wall 122 and the proximal wall124. An outer surface of the distal wall 122 preferably faces away fromthe user while an outer surface of the proximal wall 124 preferablyfaces the user. A rim 126 (see FIGS. 1 and 2) can connect an outerperimeter of the distal wall 122 and an outer perimeter of the proximalwall 124. The envelope or pocket described above can be defined withinat least the distal wall 122 and the proximal wall 124.

The seal 114 preferably is designed to wrap around the tip or lowerportion (e.g., locations below the bridge) of the user's nose. As such,the illustrated seal 114 comprises a central portion 128 (see FIG. 1)positioned between side portions or wings 130. The central portion 128can underlie the user's nose and preferably incorporates the nostrillocators 120. In some configurations, the central portion 128 can extendupward over a tip of the user's nose. In other configurations, thecentral portion 128 does not extend upward over the tip of the user'snose. The wings 130 can form at least a portion of the lateral portions110 discussed above. The wings 130 can be configured to extendcompletely or substantially completely over the sides of the user's noseand may extend at least partially over the user's cheeks.

As described above, at least a substantial portion of the seal 114 canbe supple. For example, a region surrounding the nostril locators 120can be more supple than at least a portion of the wings 130. At leastthe proximal wall 124 and the rim 126 of each side portion can be verysupple so that they can expand to conform to the contours of the user'sface, and in particular, to the contours of the outside flanks of theuser's nose. Preferably, the supple portions of the seal 114 are ofsufficient dimension and shape that, when the inflated seal is pressedagainst the face of the user with the nostril locators 120 engaged inthe nostrils of the user, the seal 114 conforms to the surfaces of theuser's face (i.e., at least the sides of the nose and along at least aportion of the upper lip).

Select portions of the seal 114, however, can have an increased rigidityto improve the form, fit and function of the mask 102. For example, atleast a portion of the rim 126 can be significantly stiffer to providecontrol to ballooning of other regions of the seal 114. In addition, aregion adjacent to and including an inlet opening (e.g., the portionthat receives the flow of gases from the conduit 106) of the seal 114can be less supple. Thus, the distal wall 122 can have a decreasingsuppleness from the wings 130 to the central portion that contains theinlet opening. The less supple regions can be formed of a differentmaterial or can be formed of the same material but with an increasedthickness.

As described above, the frame 116 supports the seal 114. In someconfigurations, an inlet opening of the seal 114 can be fitted to theframe 116 and the flexible conduit 106 also can be fitted to the frame116 such that gases can be provided to the seal 114 through the frame116. In other configurations, the seal 114 directly connects to theflexible conduit 106. In some configurations, the seal 114 can beconnected to the conduit 106 with the central connection 112.

The frame 116 may have any suitable arrangement for securing the seal114. In some configurations, an annular wall can extend from a proximalside of the frame 116 around a perimeter of an opening that extends tothe connector 112. The annular wall can include an outwardly extendinglip. The inlet opening of the seal 114 can engage over the outwardlyextending lip of the annular wall. In some configurations, the inletopening of the seal 114 can be stretched to fit over the annular wall.The inlet opening of the seal 114 may be provided with a thickened orreinforced wall section, for example but without limitation. In someconfigurations, an extended portion of the seal 114 can be rolled upover the annular wall of the frame 116. In another configuration, theseal 114 can be provided with a portion of a connector and at least oneof the frame 116 and the conduit 106 may include a complementaryconnector portion.

The frame 116 can be designed to be minimal in size. Advantageously, thesmall size of the frame 116 enables a clear field of vision for the userand allows the user to wear glasses while wearing the interface 100.Preferably, the frame 116 is formed from an elastomeric material, whichwill allow the frame 116 to flex to conform slightly to the face of theuser. The frame 116, however, provides support for the seal 114. Byproviding support for the seal 114, the seal can be more effectivelypressed into contact with the face and around the nose of the user. Theframe 116 can be formed by injection molding, preferably from anelastomeric material, such as silicone or polyurethane, for example butwithout limitation. In some configurations, the frame 116 can be formedof more rigid materials, such as polycarbonate, polyester polystyrene,or nylon, for example but without limitation.

In use, the portions of the supple proximal wall 124 that are above,below and to each side of the nostril locators 120 can be inflated bypressure inside the seal 114 (e.g., inflated from the flow of gasessupplied to the patient interface 100) to press against the skin of theuser and conform to contours of the outside surfaces of the nose of theuser, to surfaces of the lower portion of the nose of the user and tosurfaces of the upper lip of the user immediately below the nose.Movement of the mask 102 is not likely to significantly break this sealwith the face because the supple perimeter or periphery of the seal 114allows the mask 102 to move in all directions (other than directly awayfrom the face) to at least a small extent. The supple portions of theseal 114 somewhat decouple the position of the nostril locators 120 fromthe position of the mask 102, which decoupling allows the mask 102 todisplace somewhat in at least one or both of the lateral and verticaldirections (i.e., lateral and vertical relative to axes of the patient'sface). The wings 130 engage the sides of the user's nose and form anadditional seal. The wings 130 also support the location of the mask.

With reference to FIG. 4, when donning the interface 100, the mask 102can be opened by spreading the wings 130 apart, which increases theangle between the wings 130. With the wings 130 having been pulled open,the nostril locators 120 (see FIG. 3) that are positioned on theproximal wall 124 better present toward the user and guide the locationof the mask 102 onto the face of the user. With the nostril locators 120properly positioned, the mask 102 can be secured in position with thestrap 104, which forms a loop around the head of the user at a locationvertically higher than the ears. Other techniques for donning theinterface also can be used.

As described above, when donning the interface 100, the seal 114preferably is folded or spread open in order to improve fit and to helpachieve a desired positioning. In the configuration of FIGS. 1-4,however, spreading open the seal 114 generally requires that fingers bepositioned between the seal 114 and the face of the user, which can beawkward for users. In addition, it can be difficult to open the seal 114with a single hand such that the other hand can be used to bring thestrap 104 into position.

With reference to FIG. 5, an interface 100 a is shown with a sealmanipulation assembly 140. For clarity, a seal 114 a of the interface100 a is shown enlarged and without a frame 116 a in the lower portionof FIG. 5 and connected to the frame 116 a in the upper portion of FIG.5. The seal manipulation assembly 140 preferably comprises a pair ofpads 142. The pads 142 extend outward from the seal 114 a. In someconfigurations, the pads 142 are positioned along the distal surface 122a. In some configurations, the pads 142 extend outward from the distalsurface 122 a. In some configurations, the pads 142 are integrallyformed with the seal 114 a. In some configurations, the pads 142 areseparate components from the seal 114 a. In the illustratedconfiguration, a frame 116 a of the interface 100 a comprises recesses144 that receive at least a portion of the pads 142. The seal 114 aunderlies the frame 116 a in the region of the pads 142. In someconfigurations, the seal 114 a is not secured to the frame 116 a in theregion of the pads 142 or proximal of that region such that the seal 114a can be moved relative to the frame 116 a.

The pads 142 are connected to an operating mechanism of the sealmanipulation assembly 140. In some configurations, the pads 142 areconnected to scissor arms that extend within the seal 114 a. The scissorarms can cross and be connected with a hinge such that squeezing of thepads 142 toward each other can result in the ends 146 of the seal 114 amoving apart from each other.

In some configurations, the operating mechanism is simpler than thescissor mechanism described directly above. For example, with referenceto FIG. 6, which is a simplified representation of an operatingmechanism, the pads 142 connect to, or are integrally formed with, arms150. The arms can extend toward the ends 146 of the seal 114 a. The arms150 can have a length that is longer than the length of the pads 142. Aforward portion of the arms 150 can be held apart from each other usinga cross member 152. In some configurations, the material of the seal 114a, the frame 116 a or the seal 114 a and the frame 116 a combined may bestiff enough to allow separation or spreading of the ends 146 of theseal 114 a through manipulation of the pads 142 without including thecross member 152. By holding the arms 150 apart at a location betweenthe pads 142 and the ends 146, depressing the pads 142 toward each otherwill result in the ends 146 moving apart from each other. In someconfigurations, the arms 150 can be joined together by a living hinge,by a rigid connection to a flexible cross member that elasticallydeforms or by a pin joint or the like.

By manipulating the shape of the uninflated seal 114 a (e.g., byseparating the ends 146 a to alter how the seal 114 a initially presentsitself to the user), the seal 114 a is opened for placement onto theface of the user. Once in place, the seal 114 a can be inflated, whichcauses the seal 114 a to swell around the nares of the user.

With reference now to FIG. 7, another seal 114 b is illustrated. Theseal 114 b has been provided with another seal manipulationconfiguration 140 b. In the illustrated seal 114 b, the sealmanipulation configuration 140 b can be attached to or integrally formedwith a portion of the distal wall 122 b. Preferably, the sealmanipulation configuration 140 b is positioned along the distal wall 122b along the lateral portions 110 b or wings 130 b.

The seal manipulation configuration 140 b can take any suitableconfiguration. In some configurations, for example but withoutlimitation, the seal manipulation configuration 140 b comprises walls154 that can define loops of material into which fingers can beinserted. In the illustrated configuration, the seal manipulationconfiguration 140 b comprises pockets 156. Each of the pockets 156 canhave a rim 160 at the distal end. The rim 160 can define an openingsufficiently large to receive a finger tip. The proximal end of each ofthe pockets 156 can be enclosed or open. In the illustratedconfiguration, the proximal end of each of the pockets 156 is enclosed.

In some configurations, a surface feature 158 can be provided adjacentto the opening defined by the rim 160. The surface feature 158 can be arecess or a surface texture. The surface feature 158 can be positionedjust forward of the opening to guide fingers into a desired location.The surface feature 158 can provide additional clearance to facilitateinsertion of the fingers.

By positioning the pockets 156 on the outside of the seal 114 b, fingerscan be inserted into the pockets 156 and the pockets 156 can be used toprovide an outward force on the wings 130 b to open the seal 114 b forpresentation to the face.

With reference now to FIG. 8, a mask 102 c can have a seal 114 c thatfeatures integrated arms 170. In the illustrated configuration, the arms170 can extend along an outer portion of the distal wall 122 c. With thearms 170 integrated into the seal 114 c, the frame 116 can be omitted,integrated directly into the seal 114 c or remain a separate supportingelement. When integrated into the seal 114 c, the mask frame 116 can bedefined by a region of increased stiffness (i.e., a region of lesssuppleness). For example, when integrated into the seal 114 c, the maskframe 116 features can be replaced with regions of increased thicknessor overmolded characteristics.

In the illustrated configurations, the integrated arms 170 extendproximally from a distal region of the distal wall 122 c. Preferably,each end 146 c is separated from the associated arm 170 such that theends 146 c can move without significant movement of the overlyingportion of the arms 170. In other words, the connection between the arms170 and the distal wall 122 c can terminate distally of the end 146 csuch that at least a portion of the arm 170 overlies, but is notdirectly connected to, the proximal end of the distal facing wall 122 c.

In the illustrated configuration, an attachment member 172 can be formedat the proximal end of each arm 170. The attachment member 172 can haveany suitable configuration and can be used to connect the arms 170 to astrap (not shown) or other headgear assemblies. In the illustratedconfiguration, the attachment member 172 comprises a post 174 that ispositioned within a recess 175. The strap or other headgear can bepassed around the post 174 or secured with a hook member to the post 174for example but without limitation.

FIGS. 9A-9F illustrate seals 114 d having differing surface texturesalong at least a portion of the proximal wall 124 d. The surfacetextures can be positioned along any portion of at least the proximalwall 124 d. In some configurations, the surface textures can bepositioned along a proximal portion of the proximal wall 124 d. In someconfigurations, the surface textures are only positioned along aproximal portion of the proximal wall. In some configurations, thesurface textures can be positioned on other surfaces but, with respectto the proximal wall 124 d, the surface textures are only positionedproximally of any nostril locators 120 d.

FIGS. 9A-9F illustrated the following surface textures: slots 176;recesses 180; scallops 182; plateaus 184; and ribs 186. Any othersuitable surface textures, including shapes, recesses and protrusions,can be provided to the proximal wall 124 d of the seal 114 d. In someconfigurations, a combination of surface textures, including but notlimited to those described herein, can be used.

In some configurations, the textured portions are positioned outboard ofthe nostril locators 120 d. In some configurations, the texturedportions are positioned entirely outboard of the nostril locators 120 d.In some configurations, the textured portions can surround, generallysurround or be positioned generally adjacent to the nostril locators 120d. In such locations, the textured portions can reduce the contactsurface area with the skin of the user while still maintaining anadequate seal against the face of the user. By reducing the contactsurface area between the face of the user and the seal 114 d, thecontact region is perceived by the user to be cooler. Because, in someconfigurations, other regions besides the regions having the texturedsurfaces define a primary seal with the face, the textured surfaces canimprove comfort without significantly deteriorating the seal presentbetween the seal 114 d and the face.

The interface illustrated in FIGS. 1-4 is a construction that hasintegrated both the seal 114 and the nostril locators 120 into a singlecomponent. With reference now to FIGS. 10-12, the interface also cancomprise masks with separable nostril locators and seals. By providingseparability between the seal and one or more of the nostril locators,the mask can be better adapted for use by users having different facialgeometries. For example, different separable components can havedifferent sizes. In some configurations, the inflating seal can beuniversal while the nostril locators can be exchanged depending upon thesize desired by the user. In some configurations, the seal could beprovided in different geometries, such as, for example but withoutlimitation, a wide version and a narrow version.

With reference now to FIG. 10, the illustrated interface 100 e comprisesa seal 114 e with a separable nasal insert 190 and seal member 192.While the seal 114 e is formed from more than one component, the seal114 e otherwise can be configured generally in the same manner as theseal 114 shown in FIGS. 1-4 and described above. For example, the seal114 e can be configured with more supple and less supple regions similarto the seals disclosed above.

The nasal insert 190 comprises at least one nostril locator 194. Thenostril locators 194 can sit atop a main body 196. In the illustratedconfiguration, two nostril locators 194 are integrally formed with themain body 196. In some configurations, the two nostril locators 194 canbe separable from the main body 196.

The main body 196 comprises a plug portion 200 and the seal member 192comprises a socket portion 202. The plug portion 200 can be receivedwithin the socket portion 202 as indicated by the arrow in FIG. 10. Insome configurations, the plug portion 200 locks into position within thesocket portion 202. In some configurations, the plug portion 200 issecured by a friction fit within the socket portion 202. Other suitabletechniques for securing the plug portion 200 and the socket portion 202can be used.

A distal end 204 of the main body 196 comprises an inlet opening and,proximally of the inlet opening, the main body 196 comprises one or moreopenings 206. The inlet opening can be connected to the flexible supplyconduit 106. The seal member 192 comprises one or more internal voids oropenings 208 and, when the plug portion 200 is positioned within thesocket portion 202, the one or more internal voids or openings 208 canbe in fluid communication with the one or more openings 206. Thus, inthe configuration of FIG. 10, the gases flow from the flexible conduit,into the nasal insert 190 and a portion of the gases flow from the nasalinsert 190 into the seal member 192 while a portion of the gases flowfrom the nasal insert 190 through the nostril locators 194 to the user.

With reference to FIG. 11, a nasal insert 190 a and a seal member 192 acan combine to define a mask. The nasal insert 190 a can have an inletat a plug portion 200 a, which is located at a distal end of the nasalinsert 190 a. The inlet can be formed by the plug portion 200 a. Theseal member 192 a, however, can have a distal inlet (not shown) thatconnects directly to a supply conduit (i.e., connects to the supplyconduit rather than receiving flow from the nasal insert 190 a) and anoutlet that connects to the nasal insert 190 a. The nasal insert 190 amay include but does not require the openings used in the configurationof FIG. 10. Thus, in the configuration shown in FIG. 11, gases aresupplied to the seal member 192 a first and the seal member 192 a passesthe gases on to the nasal insert 190 a through the inlet at the distalend of the nasal insert 190 a prior to the nasal insert 190 a passingthe gases from the nasal insert 190 a to the nostril locators 194 a.

With reference now to FIG. 12, a further multi-piece seal constructionwill be described. The multi-piece construction enables customization ofthe seal to the user. For example, different size nostril locators canbe used with a universal seal member or different size seal members. Inaddition, nostril locators having differing stiffness or rigidity can beused and/or seal members with different levels of stiffness can be used.In some configurations, the seal member and the nostril locators can beformed of the same material. In some configurations, the seal member andthe nostril locators can be formed of differing grades of the samematerial.

The seal member 192 b shown in FIG. 12 comprises one or more outletopenings 208 formed on a proximal surface. In the illustratedconfiguration, the seal member 192 b comprises two openings 208 thatreceive individual nostril locators 210. The openings 208 can definesockets while distal ends 212 of the nostril locators 210 can defineplugs. As illustrated in FIG. 12, the distal ends 212 fit into theopenings 208. The nostril locators 210 can be connected to the sealmember 192 b in any suitable manner. In some configurations, the nostrillocators 210 can be friction fit into the openings 208. In someconfigurations, the distal ends 212 and the openings 208 can beconfigured to connect in only one rotational orientation. In someconfigurations, the rotational orientation can be varied to customizethe fit of the nostril locators 210. In some configurations, therelative rotational orientation between the openings 208 and the nostrillocators 210 can be indexable such that the two can be rotationallyadjusted and secured in a desired rotational position.

With reference now to FIG. 13, a seal 214 is illustrated that features aseparable nasal insert 216 and seal member 218. The seal 214 can besimilar to the construction of any of the configurations describedabove. In some configurations, however, the nasal insert 216 comprisesan auxiliary component 220. As illustrated in FIG. 13, the auxiliarycomponent 220 can be positioned between the one or more nostril locators222 and a base 224 of the nasal insert 216. In some configurations, arim 230 can encircle the one or more nostril locators 222 and theauxiliary component 220 can be positioned between the rim 230 and thebase 224. In some configurations, the rim 230 can be positioned betweenthe one or more nostril locators 222 and the auxiliary component 220. Inthe illustrated configuration, the base 224 of the nasal insert 216 cancomprises one or more opening 226 but need not.

The seal member 218 can be supple, as described above. In theillustrated configuration, the seal member 218 comprises an opening 228that receives at least a portion of the nasal insert 216. The opening228 and the auxiliary component 220 are supple enough to enable theauxiliary component 220 of the nasal insert 216 to be inserted into thepocket defined within the walls of the seal member 218. In someconfigurations, the opening 228 seals about a portion of the nasalinsert 216 between the auxiliary component 220 and the rim 230.

The rim 230 and the auxiliary component 220 can be separated by a gap, arecess, a channel, or a groove, for example but without limitation. Theseal member 218 can include a lip that is received within the gap,recess, channel or groove that can be defined between the rim 230 and atleast a portion of the auxiliary component 220. In other words, theauxiliary component 220 can overlie, and can be separated from, at leasta portion of the rim 230. The gap between the auxiliary component 220and the rim 230 can be sized and configured to receive at least aportion of the seal 214. In this manner, the seal member 218 and thenasal insert 216 can be secured together, for example but withoutlimitation. Moreover, in the illustrated configuration, the seal member218 and the nasal insert 216 can be sealed together.

With reference now to FIGS. 14A-14D, a sampling of differentconstructions of auxiliary components will be described. A nasal insert216 a is shown in FIG. 14A in which the auxiliary component 220 acomprises a slightly curved blade member 232. The blade member 232extends laterally outward beyond the nostril locators 222 a andlaterally outward beyond an outermost extent of the rim 230 a thatgenerally encircles the nostril locators 222 a. The blade member 232 canbe formed integrally with the nasal insert 216 a or can be formedseparate of the nasal insert 216 a and secured thereto in any suitablemanner. In some configurations, the blade member 232 is formed ofsilicone. The blade member 232 can be a resilient member that has theability to bend into a first position and a second position. In someconfigurations, the blade member 232 can be a member that isbi-directionally stable. In other words, the blade member 232 can assumetwo distinct positions with sufficient stability to remain at leasttemporarily in those positions. In some configurations, the blade member232 has sufficient resilience to assume a first shape or position whenthe associated seal member 218 a is underinflated or not inflated. Insome configurations, the blade member 232 will bend or deflect when theassociated seal member 218 a is inflated for use. Such a configurationis shown in FIG. 14A in which the outermost portions of the blade member232 have been deflected upwardly.

As shown in FIG. 14A, the blade member 232 provides added material thatcontacts one or more inner surface of a seal member. The blade member232 can be configured to urge the seal member 218 a into an openposition to assist with fitting of the mask on the face of the user bycan deflect out of the way during use of the interface by the user. Byslightly opening the mask, the nostril locators 222 a can be mated withthe nostrils more easily. Once gas pressure is supplied to the sealmember 218 a, the seal member will inflate and balloon into sealingengagement with the face of the user. Preferably, the blade member 232is supple enough that, once the seal member 218 a starts to inflate, theblade member 232 can bend and conform to the shape of the seal member218 a such that the seal member 218 a can inflate and seal around thenose of the user.

FIG. 14B illustrates a nasal insert 216 b that is similar in somerespects to the nasal insert 216 a shown in FIG. 14A. A rim 230 b of thenasal insert 216 b in FIG. 14B comprises a loop member 234. The loopmember 234 is similar to the blade member 232 in some respects; however,the loop member 234 extends both proximally and distally while alsoextending laterally outward. In other words, as apparent from comparingFIG. 14A with FIG. 14B, while the blade member 232 is generally a flatdish-shaped component in FIG. 14A, the loop member 234 is less flat andextends both fore and aft. As such, the loop member 234 facilitatesmanipulation of the proximal portion of the associated seal member 218 bbut also facilitates manipulation of the distal portion of the sealmember 218 b. In other words, whereas the blade member 232 contacts theinner surface on the distal portion of the seal member, the loop member234 is capable of contacting the inner surfaces on the proximal anddistal portions of the seal member 218 b.

With continued reference to FIG. 14B, the loop member 234 extendslaterally outward of the nostril locators 222 b and outward beyond anoutermost extent of the rim 230 b. The loop member 234 can be formedintegrally with the nasal insert 216 b or can be formed separate of thenasal insert 216 b and secured thereto in any suitable manner. In someconfigurations, the loop member 234 can be formed of silicone.

By contacting the inner surfaces of the seal member 218 b, the loopmember 234 places the seal member 218 b in an opened position prior toinflation of the seal member 218 b and provides an initial shape to thedeflated seal member 218 b. Once gas pressure is supplied to the sealmember 218 b, the seal member 218 b will inflate and balloon intosealing engagement with the face of the user. Preferably, the loopmember 234 is supple enough that, once the seal member 218 b starts toinflate, the loop member 234 can bend and conform to the shape of theseal member 218 b such that the seal member 218 b can inflate and sealaround the nose of the user. In some configurations, the loop member 234can toggle between two positions. In some configurations, the loopmember 234 can be structured to simply deflect out of the opened orfirst position as the seal inflates but resume the opened or firstposition when the seal once again deflates.

FIG. 14C illustrates a nasal insert 216 c having an auxiliary component220 c that is inflatable. The auxiliary component 220 c comprises one ormore stabilizers 236. The stabilizers 236 can have one or more outerwall and can be inflatable. Thus, an inner pocket defined within thestabilizer 236 can communicate with a gas source, such as the flowthrough the associated seal member 218 c. In the illustratedconfiguration, the stabilizers 236 can be connected to the base 224 c ofthe nasal insert 216 c. The ballooning stabilizers 236 can provide aforce to urge the proximal surface of the seal member toward the face ofthe user when at operating pressures. Thus, different from the loopmember 234 and the blade member 232, the ballooning stabilizers 236 donot serve to hold the uninflated mask in an open position; thestabilizers 236 provide an improved sealing force during use.

With reference to FIG. 14D, a nasal insert 216 d is illustrated with anauxiliary component 220 d that can flex between a first position P1 anda second position P2. The auxiliary component 220 d can comprise a dishmember 238 that is stable in the first position P1 and in the secondposition P2. In some configurations, the dish member 238 can flipbetween the first position P1 and the second position P2 but will returnto the first position P1 with the application of minimal force. As shownin FIG. 14D, the dish member 238 can be flexed into the second positionP2 for donning of the mask. With the dish member 238 in the secondposition P2, the seal member 218 d can be held in the open position.Once positioned as desired on the user, a slight urging of the dishmember 238 toward the face of the user causes the dish member 238 to popback into the first position P1, which allows the seal member 218 d tomove to a more closed position.

Accordingly, to don the mask with the assembly illustrated in FIG. 14D,the dish member 238 can be flexed from the first position P1 to thesecond position P2. The dish member 238 temporarily is stabilized in thesecond position as the mask is being positioned such that the nostrillocators 222 d can be positioned within the nostrils of the user. As themask is brought into engagement with the face of the user, the forcesapplied through the seal member 218 d transfer to the dish member 238,which pops back or otherwise returns to the first position P1. With thedish member 238 in the first position, the seal member 218 d can closearound the tip of the nose of the user, which allows the mask with theassembly illustrated in FIG. 17 to seal around the tip of the nose ofthe user.

With reference now to FIG. 15A, a portion of a seal member 250 is shown.The seal member 250 can be configured in accordance with any combinationof features of any of the constructions described within thisspecification, for example but without limitation. The seal member 250can comprise a distal wall 252 and a proximal wall 254. An opening 256can be defined within the distal wall 252. A supply of gases can passinto the seal member 250 through the opening 256.

As shown in FIG. 15A, the distal wall 252 can have a thickercross-section, for example, relative to the proximal wall 254. Thethicker cross-section provides increased rigidity to the distal wall 252relative to the proximal wall 254. In some configurations, the thicknessof the walls can be the same while the material used has an increasedrigidity. In some configurations, both the thickness and the rigidity ofthe material can be used to provide differing degrees of rigidity.

In the illustrated configuration of FIG. 15A, a nostril locator 260 canbe positioned along the proximal wall 254. The illustrated nostrillocator 260 can generally taper such that it narrows toward a proximalopening 262. As such, the proximal opening 262 may have a smallerdiameter than a distal opening into the nostril locator 260. Generallyspeaking, the nostril locator 260 can taper in a proximal direction.

To improve lateral stability of the mask assembly, outriggers or othersupport structures can be used. In the configurations illustrated inFIGS. 15A-15D, however, the support structures are shown integrated intothe structure of the seal member 250 itself. With reference to FIGS.15A-15C, a support structure 270 is shown that is integrated into theseal member 250. With the integrated support structure 270, the mask ismore comfortable than other masks that might use separate supportstructures that are more rigid than the seal member. Moreover, becausethe support structure 270 can be directly adjacent to the user's face,the integrated design provides for better support to the sealing member250.

The illustrated support structure 270 can be one or more thickenedregions. For example, where the seal member 250 if formed of silicone,the support structure 270 can be a thickened region of silicone. In somesuch configurations, the support structure 270 can be molded into theseal member 250. In some configurations, foam could be injected orinserted into the support structure 270. For example, in some suchconfigurations, the support structure 270 can be formed with a hollowregion (or material could be removed) and the region can be filled withany desired gel or foam substance. In some configurations, the supportstructure 270 can be formed of silicone and the hollow region can befilled with a different grade of silicone. Such composite supportstructures can reduce the weight of the seal and mask assembly.

By molding the support structure 270 into the seal member 250, thesupport structure can flex with the seal member 250. Flexing of the sealmember 250 allows the seal member 250 to better fit different faceshapes. Additionally, the support structure 270 can move with the sealmember 250 and the seal member 250 can sit closer to the face.Furthermore, integration of the support structure 270 into the sealmember 250 simplifies manufacture of the mask because, by integratingthe support structure 270 into the seal member 250, the supportstructure is not separately formed or formed by an overmolding process.Moreover, the integration reduces the weight of the assembly while alsofacilitating a reduced size.

With reference to FIGS. 15A-15C, the illustrated support structure 270is a crescent shaped member that generally underlies the seal member250. With reference to FIG. 15D, in some configurations, the supportstructure 270 can wrap upward along one or more of the outer (distal)side walls 252. Thus, as shown, the support structure 270 can beprovided in a variety of shapes. The shape of the support structure 270can be tailored to provide support to the seal member 250 whereverdesired because the support structure 270 can be molded in an integratedconstruction. While the configuration of FIGS. 15A-15C illustrate astructure that provides support just above a lip region of a user, theconfiguration of FIG. 15D reassigns the support to a cheek region ratherthan the fairly narrow region above the lips and below the nose. Thus,in the configuration of FIG. 15D, the support is shifted to the outsidetoward the cheeks, away from the upper lip. In some configurationssimilar to the configuration of FIG. 15D, the support remains on aboutthe bottom half of the seal member 250 even though the support structure270 wraps vertically upward along the sidewall. By shifting the supportstructure 270 location, the comfort of the seal member 250 can beimproved while also improving the performance of the seal member 250.

With reference now to FIGS. 16-18, another mask seal member 280 isillustrated. The mask seal member 280 comprises a distal wall 282 and aproximal wall 284. One or more nostril locators 286 can be positioned onat least a portion of the proximal wall 284. The nostril locators 286can have any suitable configuration. In some configurations, the nostrillocators 286 taper upwardly to openings 288.

As illustrated in FIG. 17, the proximal wall 284 wraps proximally aroundthe nostril locators 286 Moreover, the illustrated nostril locators 286span a portion of the proximal wall 284 that is generally normal to avertical bisecting plane P as well as a portion of the proximal wallthat wraps proximally. Other configurations are possible. In theillustrated configuration, the proximal wall 284 extends more proximallythan the proximal most portion of the nostril locators 286. Because theseal member 280 has laterally extending portions 290 that wrapproximally, the laterally extending portions 290 may hold the nostrillocators away from the nares on flatter user face profiles. To helpprovide improved flexibility, the seal member 280 can be reinforced inregions closer to the nose compared to the cheeks.

With reference to FIG. 16, the seal member 280 can comprise a marginalsurface 292 that connects the proximal wall 284 to the distal wall 282.The marginal surface 292 in the illustrated configuration is wider atthe bottom than at the top. As illustrated, the marginal surface canprovide a wider portion on the bottom of the illustrated seal member280. The seal member 280 can have a thicker wall in the bottom cornerswhile the proximal wall 284 can have a reduced thickness in the regionsurrounding or at least partially surrounding the nostril locators 286.The thicker region of the bottom corners can extend upward and followthe generally vertical line illustrated in FIG. 17.

While a majority of the entire seal member 280 can be configured toballoon, the thicker regions can be configured to balloon less than theregions with a reduced thickness. The thicker regions can help controlballooning such that the proximal surface experiences a majority of theballooning compared to the marginal surface 292 and the distal surface282. Thus, the region surrounding the nostril locators 286 can balloonmore while the lower corners balloon less, which increases comfort andimproves sealing of the mask.

With reference again to FIG. 3, the nostril locators 120 typically areconfigured to be positioned within the nares. In order to fit within thenares of the user, the nostril locators 120 can be stiff enough toresist crushing during fitting and use. As such, the proximal ends ofthe nostril locators 120 have been discovered to slightly pinch theseptum or otherwise reduce the comfort of the user. Accordingly,removing some of the rigidity of the nostril locators 120, andespecially of the proximal ends of the nostril locators 120 and/or in atransition location between the nostril locators 120 and surroundingstructure (described below with reference to FIGS. 29-42), can bedesirable.

With reference now to FIG. 19, a sealing member 300 is shown incross-section. A nostril locator 302 is shown extending from a proximalsurface 304. The nostril locator 302 can include an opening 306. In theillustrated configuration, the opening 306 can be defined by a rim 308.The rim 308 preferably includes at least one interruption 310. Withreference to FIG. 19, the illustrated interruptions 310 comprise alarger opening 312 that is connected to a slot 314 that intersects withthe rim 308. In the illustrated configuration, the rim 308 includes twointerruptions 310. The interruptions 310 are positioned to be at the topand the bottom of the opening 306 in the illustrated configuration. Inother words, when positioned in the nares of the user, the interruptions310 facilitate flexure in a lateral direction in the configurationillustrated in FIG. 19.

In some configurations, the rim 308 that defines the opening 306 isgenerally elliptical and includes a longer axis L1 and a shorter axisL2, as shown in FIG. 19. In such configurations, the interruptions 310can be intersected by the longer axis L1. In some configurations, one ormore interruption 310 can be positioned along the portion of the rim 308that is above the shorter axis L2. For example, a single interruption310 can be positioned on the upper side of the shorter axis L2. In somesuch configurations, the single interruption 310 can be positionedcloser to the apex of that portion of the elliptical opening 306. Insome such configurations, the single interruption 310 can be intersectedby the longer axis L1. In some such configurations, the singleinterruption 310 can be centered upon the longer axis L1.

With continued reference to FIG. 19, the interruptions 310 definerecesses into the nostril locators 302 that extend from the rim 308 intothe material of the nostril locators 302. The interruptions 310 canextend any suitable distance along the length of the nostril locator302. The length preferably is not so long as to create a leak path butlong enough to allow some radial relief to the rim 308. As the length ofthe interruptions 310 increases, the stiffness of the nostril locator302 decreases.

With reference to FIGS. 20A-20E, other configurations of interruptions310 are illustrated. As illustrated, the interruptions 310 can have manydifferent shapes and can be moved away from a region of the nostrillocators 302 that will contact the septum. As illustrated, theinterruptions 310 can be as few as one or as many as desired. In someconfigurations, the interruptions 310 result in a serrated end to thenostril locator 302. Other configurations also are possible.

With reference now to FIGS. 21 and 22, a sealing member 330 isillustrated. The sealing member 330 can have features, aspects andcharacteristics in common with any other configuration described herein.In the illustrated configuration, the sealing member 330 comprises atleast one flexible prong 332. In some configurations, the sealing member330 can comprise two flexible prongs 332. The flexible prongs 332comprise a distal end that is connected to a proximal surface 334. Theflexible prongs 332 can extend generally proximally from the proximalsurface 334. The flexible prongs 332 can have one or more opening 336that are positioned generally at a proximal end of the prongs 332. Inthe illustrated configuration, the opening 336 can form a slit thatextends generally vertically through the proximal most end.

The prongs 332 preferably comprise a stalk 340 that extends generallybetween the proximal surface 334 and the opening 336. The stalk 340 canbe configured to roll or otherwise deflect with ease. For example, across-sectional thickness of the material used to form the sealingmember 330 and/or the flexible prongs 332 can be reduced that connectsat least a portion of the prongs 332 to the sealing member 330. In someconfigurations, a different material or a different grade of materialcan be used to provide increased mobility to the prongs 332.

In the illustrated configuration, as shown by comparing FIG. 21 and FIG.22, the prongs 332 can be configured to telescope or extend/retract. Byconfiguring the prongs 332 to extend, the prongs 332 can have increasedflexibility. As illustrated, the prongs 332 can compress along the axialdirection. By compressing, the prongs 332 can improve comfort whensealing against the nares of the user.

In some configurations, the prongs can be configured with a bellows-typeshape. The bellows-type shape can provide axial compressibility. Thepleated appearance of the bellows-type shape can be formed along all ofthe stalk 340 or just a portion of the stalk 340. By providing thebellows-type shape, the stalk 340 also can allow the proximal end of theprongs 332 to wobble about the distal end of the prongs 332. In otherwords, the proximal end of the prongs 332 can bend in all directionswithout rotation of the prongs 332.

With reference now to FIGS. 23A-23C, a portion of a sealing member 350is shown. In some configurations, the sealing member 350 includesnostril locators 352 similar to those described above. At least aproximal portion of the nostril locators 352 can be partially or fullycovered with an end member 354, as shown in each of FIGS. 23A-23C. Theend members 354 can be formed of a material that is as soft as, orsofter than, the material of the nostril locator 352. In someconfigurations, the end members 354 can be partially or fully formed ofa softer silicone material. In other words, the end members 354 can beused to provide increased comfort by being positioned over the proximalend of the nostril locators 352.

The end member 354 can define openings 356 through which airflow fromthe nostril locator 352 can pass. In the illustrated configurations, theend members 354 have a rounded appearance. The softer material and therounded shape facilitate rolling around the axis of the nostril locator352. The underlying nostril locator 352 can be sufficiently rigid toprovide the structure while the cap formed by the end member 354 canimprove the comfort. In some configurations, the proximal end of thenostril locator 352 can be enclosed with perforations or laterallyextending openings to allow air to flow out of the nostril locator whilethe soft end member creates a seal with the nares of the user. Inaddition, in some such configurations, the end member 354 can have alarger outer diameter than the nostril locator 352 such that the nostrillocator 352 can have improved flexibility while the end member providesan effective sealing component.

With reference now to FIG. 24, a further seal member 360 is illustrated.The seal member 360 includes a multiple wall nostril locator 362. In theillustrated configuration, the nostril locator 362 comprises a thinouter wall 364 and a thicker inner wall 366. In some configurations, theouter wall 364 is spaced from the inner wall 366 such that the two wallsare capable of relative movement. In some configurations, the inner wall366 can terminate within the outer wall 364. In other words, the outerwall 364 may extend further proximally relative to the inner wall 366.

The inner wall 366 can comprise a foam or gel insert, for example butwithout limitation. The inner wall 366 underlies and supports the outerwall 364. Thus, with the support of the separately formed inner wall366, the outer wall 364 could be formed of a very thin layer. In someconfigurations, the outer wall 364 can be a very thin silicone wall thatis intermittently or substantially completely supported by the innerwall 366, which can be a much softer material than the outer wall 364.

With reference now to FIGS. 25A and 25B, a seal member 380 isillustrated therein. The seal member 380 can include one or more nostrillocators 382. In some configurations, the seal member 380 can beconfigured such that the nostril locators 382 direct the airflow in amore upward direction. With reference to FIG. 25A, the nostril locators382 are shown directing the airflow more rearwardly when compared to thenostril locators 382 shown in FIG. 25B. By raising the rearmost wall ofthe nostril locators (see 384), for example, the trajectory of theairflow can be altered to a more upwardly directed flow. In someconfigurations, the nostril locators are configured such that theresultant airflow is more upwardly and forward. By redirecting theairflow in this manner, the airflow is not blown straight into the nose,which improves the comfort to the user. In some configurations, thenostril locators 382 can be positioned on a ball joint, for example butwithout limitation, such that the air flow can be tuned by the user asdesired.

With reference now to FIG. 26, the illustrated seal member 400 can bestructured in any configuration described above. The configurationillustrated, however, features a proximal surface 402 that omits one orboth nostril locators. In the illustrated configuration, one or more ofthe nostril locators is replaced by an opening 404 that is formed in theproximal surface 402. Thus, the nostrils of the user can simply overliean opening 404 that is formed in the proximal surface. The configurationof FIG. 27 shows a single opening 404 that can underlie one or bothnostrils of the user while the configuration of FIG. 28 also shows asingle protrusion 406 that can help indicate to the user when the maskis properly located under the nose. With reference to FIG. 28, in someconfigurations, the tip of the nose can sit at the crossing 408 of thetwo facet lines. The protrusion 406 can be a short nostril locator, acomplete nostril locator or any other suitable structure to help theuser confirm a desired placement of the mask sealing member relative tothe nostrils. In some configurations, the nose fits into or around theopening and the seal member can balloon around the nose of the user. Forexample, the tip of the nose can go into the opening or the opening cansit under the tip of the nose to provide seal. The ballooning improvessealing of the seal member, especially where nothing extends into thenares of the user.

With reference now to FIGS. 29-42, a further interface assembly 420 isillustrated that is arranged and configured in accordance with certainfeatures, aspects and advantages of the present invention. The interfaceassembly 420 generally comprises a frame or body 422 and a seal 424. Theseal 424 can be removably secured to the frame 422 for use. In someconfigurations, multiple seals 424 can be provided for connection to theframe 422, which can vary in size, shape, softness or any otherdesirable characteristic. In the illustrated configuration, the frame422 provides attachment points for headgear or the like. Otherconfigurations are possible.

The illustrated seal 424 incorporates a connecting or mounting assembly426 that can be joined to the flexible seal member 428. With referenceto FIG. 30, the seal member 428 comprises a proximal surface 430 (i.e.,the surface that is closest to the face of the user in use) and a distalsurface 432 (i.e., the surface further away from the face of the user inuse). In the illustrated configuration, the distal surface 432 definesan inlet opening 434. The opening 434 is configured to admit breathinggases into a chamber defined within the seal member 428.

In the illustrated configuration, the opening 434 is circumscribed by arib or protrusion 436. The rib or protrusion 436 is best shown in thesectioned view of FIG. 34. As illustrated, a portion of the seal member428 that connects the rib or protrusion 436 to the distal surface 432can extend generally normal or perpendicular to an axis of the inletopening 434. Thus, the rib or protrusion 436 is offset inwardly by aportion of the distal surface 432. The radial offset allows the rib orprotrusion to be captured by the mounting assembly 426. Otherconfigurations also are possible keeping in mind a desire to surface amore rigid mounting assembly 426 to the seal member 428.

The mounting assembly 426 can be more rigid than the seal member 428. Insome configurations, the mounting assembly 426 can be formed as a twopiece construction. For example, the mounting assembly 426 can capturethe seal member 428 with an inner member 438 and an outer member 440.The inner member 438 can be inserted through the inlet opening 434.

The inner member can have a sleeve 442 that extends through the inletopening 434. The sleeve 442 can join with a larger diameter ridge 444.The larger diameter ridge 444 can provide a location against which therib or protrusion 436 of the seal member 428 can rest. The sleeve 442can be externally threaded or include one or more outer protrusions 444.The sleeve 442 also can include an inner coupler construction 446. Theouter threading or protrusions 444 can marry with a structure formed onan inner surface of the outer member 440. The outer member extendsradially outward sufficiently to capture the rib or protrusion 436 ofthe seal member 428 between the outer member 440 and the inner member438. In such a way, the mounting assembly 426 can be secured to the sealmember 428.

As described above, the sleeve 442 of the inner member 438 includes theinner coupler construction 446. The inner coupler construction 446 mateswith a corresponding structure on the frame 422 such that the seal 424(i.e., seal member 428 and mounting assembly 426) can be secured to theframe 422 for use and removed for replacement. The frame 422 can have aflange or the like with which the mounting assembly 426 is connectable.In the illustrated configuration, an inlet portion of the frame 422(i.e., a socket for a ball and socket connection) can incorporate arecess while the mounting assembly 426 can incorporate a ridge but othersuitable constructions can be used keeping in mind a desire for a secureenough connection for use but a removable connection for replacement ofthe seal 424.

In some configurations, the frame 422 and the mounting assembly 426 caninclude orientation features. For example, in the illustratedconfiguration, the mounting assembly 426 can incorporate a tongue,protrusion or boss feature 448 while the frame 422 can incorporate agroove, recess or relief feature 450. With the tongue 448 aligned withthe groove 450, the desired orientation between the seal 424 and theframe 422 can be ascertained. Other suitable configurations can be usedkeeping in mind a desire to obtain confirmation of correct alignment andorientation of the seal 424 to the frame 422.

With reference now to FIGS. 35-42, the seal member 428 of one preferredconstruction will be described in further detail. As has been described,the seal member 428 can have regions of increased suppleness and regionsof increased stiffness. The regions can result from differing materials,differing grades of the same material or differing thicknesses. In theillustrated configuration, there are regions of differing thickness. Thethickest regions on the proximal surface 430 (shown in FIGS. 35-37) andthe thickest regions on the distal surface 432 (shown in FIGS. 38-40)can be found in the rib or protrusion 436 surrounding the inlet opening434 and in a central portion of the wings 452. These regions are theregions used for mounting and for gripping and, as such, desirably arethe thickest and stiffest regions. In addition, at least in the wingregions 452, the thickest regions can support the thinner regions andprovide some structure to the seal member 428, as described below ingreater detail. In some configurations, the thickness is 3.0 mm withsome variation being possible slightly higher and lower keeping in minda desire for this region to be sufficiently rigid for mounting andgripping.

The next thickest region is the joining region 454 that joins the rib orprotrusion 436 to the balance of the seal member 428. This region simplyis thick enough to resist tearing of the seal member 428 at theconnection between the rib or protrusion 436 and the balance of the sealmember 428. In some configurations, the joining region 454 has athickness of about 1.0 mm with some variation being possible slightlyhigher and lower keeping in mind a desire to reduce or eliminate thelikelihood of tearing during normal use.

As described above, nostril locators 456 can be positioned on theproximal surface 430. The nostril locators 456 desirably aresufficiently supple to reduce or eliminate the likelihood of causingirritation. The nostril locators 456 also desirably are sufficientlystiff to reduce the likelihood of ballooning or being insufficientlyself-supporting to provide an indication to the user of correct locationand orientation of the seal 424 relative to the face. Preferably, thenostril locators 456 have sufficient stiffness to inhibit or preventsignificant collapse in response to positioning of the locators 456 inthe user's nostrils. In some configurations, the nostril locators 456can have a thickness of about 0.7 mm with some variation being possibleslightly higher and lower keeping in mind a desire to reduce userdiscomfort while still assisting with mask positioning.

As described above, some regions of the seal member 428 can beconfigured for ballooning, inflating or the like. By having suchdistensible surfaces, the seal member 428 can provide more effectivesealing while accommodating slight movements of portions of the sealmember 428 relative to the face of the user in use. In effect, thenostril locators 456 can be somewhat decoupled from the frame 422through the most supple regions of the seal member 428, which regionssurround and isolate the nostril locators 456 from the balance of themask in the illustrated configuration. As such, a surround region 458can be defined to generally encircle the nostril locators 456. Thesurround region 458 can extend to a transition between the proximalsurface 430 and the distal surface 432. In some configurations, thesurround region 458 has a thickness of about 0.25 mm with some variationbeing possible slightly higher and lower keeping in mind a desire toallow some decoupling between the relatively more rigid nostril locators456 and the balance of the seal member 428.

Other than the identified regions, the remainder of the illustrated sealmember 428 can be a transition of wall thicknesses among the identifiedwall thicknesses. The illustrated seal member 428 is but one desiredconfiguration and certain variations are possible.

As described above, as illustrated in FIG. 41 among others, the sideportions or wing regions 452 can comprise stiffened regions in the formof thickened regions 470 that support thinner regions of the body of theseal member 428, such as the surround region 458. The thickened regions470 can be mirror images of one another, as can the wing regions 452such that the seal member 428 has symmetry about a central, verticalplane. The thickened regions 470 can extend along a substantial portionof the length and/or height of the wing regions 452 or of the sealmember 428. In the illustrated arrangement, the thickened regions 470extend substantially the entire length and substantially the entireheight of the wing regions 452, which wing regions 452 can extendsubstantially the entire height and length of the seal member 428. Thus,in some configurations, the thickened regions 470 are essentially thesame size and shape as the distal surfaces 432 of the wing regions 452.

The thickened regions 470 can be of substantially constant or variedthickness. In the illustrated arrangement, peripheral portions or edgeportions of the thickened regions 470 are reduced in thickness relativeto central portions of the thickened regions 470. In particular, forwardedge portions of the thickened regions 470 reduce in thickness relativeto adjacent portions and/or central portions and transition into thejoining region 454 and rib 436 to accommodate the mounting assembly 426.Preferably, the forward edge portions of the thickened regions 470 havea greater thickness than the joining region 454 at least until ajunction between the thickened regions 470 and the joining region 454.In the illustrated configuration, the forward edge portions of thethickened regions 470 gradually reduce in thickness toward the junctionwith the joining region 454.

Similarly, rearward edge portions of the thickened regions 470 alsoreduce in thickness relative to adjacent portions and/or centralportions of the thickened regions 470. Such an arrangement preserves thesuppleness of the rearward edge portions of the proximal surface 430while inhibiting or preventing significant ballooning or distending ofthe rearward edge portions of the distal surface 432. Advantageously,such an arrangement allows the seal member 428 to provide adequatesealing functionality on outside portions of the user's nose while alsoproviding a feeling of stability for the user because any significantballooning of the rearward edge portions of the distal surface 432 canbe limited or avoided.

With reference to FIG. 41, a rearward edge of the seal member 428, whichcan also be referred to as a rim or marginal surface, can comprise atransition portion 472 between the proximal surface 430 and the distalsurface 432. In the illustrated configurations, the transition portion472 comprises a generally rounded or curved wall portion. As described,in some configurations, the thickened regions 470 begin to taper inthickness forward of the transition portion 472. However, preferably, aportion of the transition portion 472 has a greater thickness than thesupple proximal surface 430 or surround region 458 to control ballooningof the seal member 428 and, preferably, limit or prevent any substantialballooning of the distal surface 432. In the illustrated arrangement,the rearward edge portions of the thickened regions 470 taper inthickness relatively quickly toward the transition portion 472, whichthen gradually tapers in thickness from the distal surface 432 to theproximal surface 430. In some configurations, the transition portion 472can have a portion defining a wall thickness that is approximately thesame as the thickness of the supple proximal surface 430, such as thesurround region 458.

As illustrated in FIGS. 29-31, 35, 36 and 38-40, possibly among others,the lower, rearward corners of the wing regions 452 compriseoutwardly-protruding portions or outwardly-protruding corners 474. Theoutwardly-protruding corners 474 flare outwardly relative to adjacentportions of the wing regions 452 to be positioned generally at locationscorresponding to the cheek or upper lip of the user laterally outward ofthe nose. In some configurations, the outwardly-protruding corners 474are located approximately over the portions of the upper lip overlyingthe canine or cuspid teeth of the user. The outwardly-protruding corners474 can assist in anchoring the seal member 428 on the user's face. Insome configurations, this arrangement allows additional stabilityelements to be omitted while still providing the user with a sense ofsufficient stability such that the seal member 428 is the only portionof the mask that contacts the user's face. The sense of stability can becommunicated to the user at least partially due to theoutwardly-protruding corners 474 having a relatively high stiffness.Thus, preferably, the thickened regions 470 extend at least partiallyinto to the outwardly-protruding corners 474 and, in someconfigurations, can extend at least substantially completely through theoutwardly-protruding corners 474. Preferably, at least the rearmost andlowermost portions of the distal surface 432 of the seal 424 comprisethe thickened regions 470. Within the outwardly-protruding corners 474,the thickened regions 470 can taper in thickness into the transitionportion 472 as described above.

As described above, the wing regions 452 can be used as grippingportions of the seal 424 for the initial positioning of the mask on theface, repositioning of the mask on the face, removing or coupling theseal 424 from or to the frame or body 422, among other reasons. Asdescribed, the thickened regions 470 can facilitate gripping of the seal424 on the distal surface within the wing regions 452 by limitingcollapse of the seal 424 in response to squeezing of the wing regions452. In some configurations, the distal surface 432 of the seal 424 caninclude surface features (e.g., one or more recesses or protrusions)configured to facilitate gripping. Such features can be referred to asgrip surfaces or grips.

The illustrated wing regions 452 each include a grip surface 480 formedby a protrusion 482. The protrusion 482 extends outwardly from adjacentsurfaces to an extent sufficient to provide some degree of resistance toslipping of a user's fingers along the surface of the seal 424. Theillustrated protrusion 482 is generally crescent-shaped, which defines agenerally scallop-shaped grip surface 480. The ends of the protrusion482 are positioned rearward of the center, curved portion of theprotrusion 482. The user's fingers or thumb can be placed in the gripsurface 480 and the user can push against the protrusion 482 whenmounting the seal 424 to the frame or body 422. Thus, the protrusion 482compensates for the inwardly-tapered or curved shape of the seal 424that may otherwise allow the user's fingers or thumb to slide along thedistal surface 432 of the seal 424. The grip surface 480 and/orprotrusion 482 may also assist the user in removing the seal 424 fromthe frame or body 422 or otherwise positioning or repositioning themask. Other suitable grip arrangements can also be provided, such asmultiple protrusions, recesses or other surface features that enhancegrip relative to a smooth surface. Materials or material treatments thatimprove grip could also be employed.

The seal 424 could alternatively or additionally include other featuresthat define grip surfaces or grips. For example, with reference to FIGS.29, 30 and 32, the seal 424 can include a relatively rigid grip 484. Inthe illustrated arrangement, the rigid grip 484 is defined by a rigidsupport member of the seal 424, such as the mounting assembly 426 and,in particular, the outer member 440 of the mounting assembly 426. Theillustrated grip 484 is defined by a rearwardly-protruding portion ortab of the outer member 440, which can extend rearwardly of an annularportion of the outer member 440 over the distal surface 432 of the seal424. The seal 424 can define a recess that accepts the grip 484 and anouter surface of the grip 484 can be aligned with an adjacent outersurface of the seal 424. The inner member 438 can include a portion 486that also extends rearwardly in general alignment with the grip 484 butwithin the interior space of the seal 424 to capture the seal betweenthe grip 484 and the rearward extending portion 486 of the inner member438. The grip 484 can define one or more surface features 488 thatenhance grip, such as one or more protrusions or recesses.

The illustrated grip 484 is located on the top of the seal 424.Additional or alternative locations include the bottom of the seal 424or either side of the seal 424. For example, opposed pairs of grips 484can be provided on the top and bottom and/or sides of the seal 424. Insome configurations, the grip surfaces 480 and/or protrusion 482 can bedefined by a rigid structure, such as a portion (e.g., the outer member440) of the mounting assembly 426. In some configurations, the mountingassembly 426 can include protruding portions or other rigid portions canbe provided that extend a substantial length and/or height of the wingregions 452 of the seal 424.

As described above, the nostril locators 456 can be at least somewhatdecoupled from balance of the seal member 428. In some configurations,the seal member 428 can be configured to provide for or facilitatepreferential movement of the nostril locators 456. In some suchconfigurations, the seal member 428 can be configured to provide lessresistance to tilting movement in at least one direction relative to atleast one other direction. Preferably, the seal member 428 includes oneor more features that provide for or facilitate outward tilting of thenostril locators 456 away from one another. That is, preferably, lessresistance is provided for outward tilting of the nostril locators 456relative to tilting in one or more other directions (e.g., inward,upward or downward). Such an arrangement can reduce discomfort thatcould otherwise occur as a result of the nostril locators 456 pinchingthe septum of the user's nose. The arrangements disclosed herein can beapplied to other types of seals or patient interfaces, such as anyarrangements incorporating nasal pillows or other sealing or non-sealingprong-like nasal elements.

Any suitable arrangement or structure can be used to provide for orfacilitate preferential movement of the nostril locators 456. In theillustrated arrangement, the seal member 428 includes thinned regionsextending around at least a portion of the nostril locators 456, whichfacilitate tilting or deflection of the nostril locators 456 and arereferred to herein as deflection regions 490. In some configurations,the deflection regions 490 are located in annular transition portionssurrounding the nostril locators 456 between the nostril locators 456and the surround region 458. The transition portions can be formedpartially or completely by the base portions of the nostril locators456, partially or completely by the portions of the surround region 458adjacent the base portions of the nostril locators 456 or a combinationof the two. In other configurations, the deflection regions 490 can beprovided in another suitable location to allow preferential deflectionof the nostril locators 456.

In some configurations, the deflection regions 490 are located on thebases of the nostril locators 456 and, in the illustrated arrangement,substantially completely on the bases of the nostril locators 456. Thedeflection regions 490 can comprise thin-walled sections of the bases ofthe nostril locators 456. The thin-walled sections have a lowerthickness than other portions of the nostril locators 456. In someconfigurations, the thin-walled sections defining the deflection regions490 can be the thinnest portions of the nostril locators 456. In someconfigurations, the thin-walled sections have a wall thickness that isabout one-half or less than about one-half of a wall thickness of asubstantial portion or a remainder of the nostril locators 456. Forexample, in some configurations, the thin-walled sections of thedeflection regions are about 0.35 mm thick and at least the primaryportions of the nostril locators 456 are about 0.8 mm thick. In someconfigurations, the tips of the nostril locators 456 are thinned forcomfort. However, with the provision of the deflection regions 490, thetips can be the same or substantially the same wall thickness as otherportions of the nostril locators 456 to improve user feedback andinhibit collapse upon insertion into the nostrils while also beingcomfortable during use. The thin-walled sections defining the deflectionregions 490 can have a greater thickness than the surround region 458.

The deflection regions 490 preferably extend around only a portion ofthe respective perimeters of the nostril locators 456. In someconfigurations, the deflection regions 490 are limited to about one-halfor less of the perimeters of the nostril locators 456. In someconfigurations, the deflection regions 490 are limited to an outer sideof the perimeters of the nostril locators 456. In the illustratedarrangement, the deflection regions 490 extend around greater than orequal to about one-third, but less than or equal to about one-half ofthe respective perimeters of the nostril locators 456.

With reference to FIG. 42 in particular, the outlet apertures 492defined by the nostril locators 456 are generally oval in shape and eachdefine a major axis 494 along the largest width of the outlet aperture492 and a minor axis 496 that is perpendicular to the major axis 494. Insome configurations, the deflection region 490 is substantially orcompletely limited to one side (e.g., the outer side) of the major axis494. A lower end of the deflection region 490 can be at or near themajor axis 494 and an upper end of the deflection region 490 can bespaced from the major axis 494. Such an arrangement can permit tiltingin an outward and slightly downward direction relative to the major axis494. The length and/or position of the deflection regions 490 can bealtered to provide for a desired direction of tilting or deflection. Insome configurations, if the lower end of the major axis 494 is assumedto be 0 degrees, the deflection regions 490 can extend from about 5degrees to about 150 degrees.

At least in part because of the provision of the deflection regions 490and other features described herein, the geometry of the seal member 428of FIGS. 29-42 has been modified relative to the geometry of the nasalseal presently commercialized by the Applicant, Fisher & PaykelHealthcare Limited, in the Pilairo® nasal mask. For example, the majoraxes 494 have been rotated toward vertical by about 10 degrees relativeto the orientations of the current Pilairo® nasal mask. Relative to acentral, vertical plane passing through the seal member 428, the majoraxes 494 are oriented at an angle of about 20-25 degrees with the lowerends of the major axes 494 being further outward (further from thecentral plane) than the upper ends of the major axes 494. The surfacedefining the tips of the nostril locators 456 have been rotatedoutwardly by about 4 degrees relative to the current Pilairo® nasal masksuch that the surfaces define an angle of about 20-25 degrees with thecentral plane with the outer portions of the tips of the nostrillocators 456 being further rearward than the inner portions. The lengthof the nostril locators 456 has been reduced by about 1 mm to about 11mm. The outlet aperture 492 defines a more round shape. For example, thedimension along the major axis 494 can be about 10 mm and the dimensionalong the minor axis can be about 5.5 mm. The nostril locators 456 arealso spaced slightly wider apart. For example, the spacing of the majoraxes 494 at the bases and the tips of the nostril locators 456 can beabout 18.5 mm and about 11 mm, respectively.

With reference to FIG. 43, a further interface assembly 500 isillustrated that is arranged and configured in accordance with certainfeatures, aspects and advantages of the present invention. The interfaceassembly 500 generally comprises a frame or body 502 and a seal 504. Theseal 504 can be removably secured to the frame 502 for use. In theillustrated configuration, the frame 502 provides attachment points forheadgear or the like. The illustrated seal 504 incorporates a connectingor mounting assembly 506 that can be joined to the flexible seal member508. The seal member 508 comprises a proximal surface 530 (i.e., thesurface that is closest to the face of the user in use) and a distalsurface 532 (i.e., the surface further away from the face of the user inuse). The interface assembly 500 is described in the context of thedifferences relative to other interface assemblies described herein.Thus, features that are not described can be assumed to be the same asor similar to corresponding features of the other interface assembliesdisclosed herein, or can be of another suitable arrangement.

The seal member 508 of FIG. 43 preferably includes features thatfacilitate or promote deflection of an upper, central portion of theseal member 508 that is aligned with the user's nose to inhibit orprevent excess pressure from being applied to the nose. In someconfigurations, portions of the seal member 508 defining both theproximal surface 530 and the distal surface 532 in the central portiondeflect forwardly to accommodate a user's nose. That is, in someconfigurations, the entire upper, central portion of the seal member 508can deflect in a forward direction rather than the proximal surface 530simply moving closer to the, often substantially stationary, distalsurface 532, which can cause stretching of the proximal surface 530 and,thus, discomfort. Deflection of the seal member 508 may not occur in allsituations. For example, certain facial geometries may result in littleto no deflection, while other facial geometries may result insignificant deflection.

The illustrated seal member 508 includes a rib or protrusion 536 thatprovides for connection to the connecting or mounting assembly 506. Ajoining region 554 can connect the rib or protrusion 536 to the balanceof the seal member 508. In some configurations, portions of the joiningregion 554 can have a thickness of about 1.0 mm with some variationbeing possible slightly higher and lower keeping in mind a desire toreduce or eliminate the likelihood of tearing during normal use.However, the upper, central portion 560 of the seal member 508, whichmay include portions of the joining region 554, preferably has a lowerwall thickness to facilitate or promote deflection (illustrated inbroken line). The wall thickness of the upper, central portion 560 canbe the same as or similar to the surround region 458 of the seal member428 of FIGS. 29-42, such as about 0.25 mm, for example. In someconfigurations, the upper, central portion 560 can be connected to orintegrated with a surround region 558, which surrounds nostril locators556 of the seal member 508. In the illustrated arrangement, the reducedwall thickness of the upper, central portion 560 begins substantiallyimmediately outward of the connecting or mounting assembly 506. Othersuitable arrangements to permit deflection and/or rolling movement ofthe upper, central portion 560 of the seal member 508 can also be used,such as the concepts and arrangements disclosed in WO 2014/062070, theentirety of which is incorporated by reference herein.

Unless the context clearly requires otherwise, throughout thedescription and the claims, the words “comprise”, “comprising”, and thelike, are to be construed in an inclusive sense as opposed to anexclusive or exhaustive sense, that is to say, in the sense of“including, but not limited to”.

Reference to any prior art in this specification is not, and should notbe taken as, an acknowledgement or any form of suggestion that thatprior art forms part of the common general knowledge in the field ofendeavour in any country in the world.

The invention may also be said broadly to consist in the parts, elementsand features referred to or indicated in the specification of theapplication, individually or collectively, in any or all combinations oftwo or more of said parts, elements or features.

Where, in the foregoing description reference has been made to integersor components having known equivalents thereof, those integers areherein incorporated as if individually set forth.

It should be noted that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications may be madewithout departing from the spirit and scope of the invention and withoutdiminishing its attendant advantages. For instance, various componentsmay be repositioned as desired. It is therefore intended that suchchanges and modifications be included within the scope of the invention.Moreover, not all of the features, aspects and advantages arenecessarily required to practice the present invention. Accordingly, thescope of the present invention is intended to be defined only by theclaims that follow.

1. A nasal seal configured to be removably coupled to a frame of apatient interface, the nasal seal comprising: a seal body formed of asoft flexible material and defining an inner cavity and one or moredelivery openings for supply of breathing gases from the inner cavity tothe patient; wherein the seal body comprises a central portion and aside portion extending from each end of the central portion, the sealbody further comprising an interior side and an exterior side, whereinthe interior side of the central portion is configured to extend acrossa base of a user's nose and the interior side of each of the sideportions is configured to extend across a side of the nose, wherein theinterior side of the seal is supple and configured to conform underinternal pressure to surfaces of the user's nose, including, at the sideportions of the seal, to outside surfaces of the side of the nose,wherein each of the side portions defines a transition portion betweenthe exterior side and the interior side, wherein the exterior side ofeach of the side portions comprises stiffened regions that are stifferor much stiffer than the supple interior side, the stiffened regionsextending to or substantially to the transition portions.
 2. The nasalseal of claim 1, wherein the stiffened regions are formed by relativelythickened portions of the seal body.
 3. The nasal seal of claim 2,wherein the thickened portions taper in thickness before the transitionportions.
 4. The nasal seal of claim 3, wherein the transition portionsinclude a portion that is thicker than the supple interior side.
 5. Thenasal seal of claim 1, wherein the stiffened regions extendsubstantially along an entire length of the exterior side of the sealbody.
 6. The nasal seal of claim 1, wherein the transition portionscomprise rounded wall sections.
 7. The nasal seal of claim 1, furthercomprising a support formed of a relatively rigid material andsupporting a portion of the seal body.
 8. The nasal seal of claim 7,wherein the support defines at least one grip surface portion extendingalong the exterior side of the seal body.
 9. The nasal seal of claim 8,wherein the at least one grip surface portion comprises at least onepair of grip surface portions substantially opposite one another. 10.The nasal seal of claim 7, wherein the support defines a mount formounting the nasal seal to the frame.
 11. The nasal seal of claim 10,wherein the mount comprises a first member that is connectable to asecond member, wherein the first member and the second member capture aportion of the seal body between them.
 12. The nasal seal of claim 11,wherein the first member is positioned within a cavity of the seal bodyand comprises a sleeve portion that extends outwardly from the cavity.13. The nasal seal of claim 12, wherein the second member surrounds thesleeve portion of the first member.
 14. The nasal seal of claim 1,wherein the stiffened regions are disposed in rearmost and lowermostsections of the side portions.
 15. The nasal seal of claim 14, whereinthe rearmost and lowermost sections of the side portions flare outwardlyrelative to adjacent portions of the seal body.
 16. The nasal seal ofclaim 1, wherein the one or more delivery openings comprises a firstdelivery opening and a second delivery opening, further comprising anostril locator associated with and forming a portion of each deliveryopening, wherein a deflection region is defined within an annulartransition portion between each of the nostril locators and asurrounding portion of the interior side, wherein the deflection regionhas a lower stiffness relative to another region of the annulartransition portion not within the deflection region.
 17. The nasal sealof claim 16, wherein the lower stiffness is achieved by the deflectionregions having a smaller thickness than the other regions of the annulartransition portion.
 18. The nasal seal of claim 16, wherein thedeflection regions are located on the outer sides of the nostrillocators.
 19. The nasal seal of claim 16, wherein the deflection regionsare limited to less than or equal to one-half of the annular transitionportion.
 20. The nasal seal of claim 1, wherein the central portion ofthe seal body defines a thinned region that permits forward movement ofan upper portion of the interior side of the central portion as a resultof rolling movement of the seal body.